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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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PACTR |
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Last refreshed on:
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29 April 2013 |
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Main ID: |
PACTR201011000264179 |
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Date of registration:
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17/11/2010 |
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Primary sponsor: |
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Public title:
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Virtual reality exposure therapy and fibromyalgia
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Scientific title:
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Virtual reality exposure therapy therapy as treatment for pain catastrophizing in fibromylagia patients: Proof-of-concept |
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Date of first enrolment:
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2011-02-07 |
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Target sample size:
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20 |
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Recruitment status: |
Not yet recruiting |
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URL:
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HTTP://www.pactr.org/ATMWeb/appmanager/atm/atmregistry?da=true&tno=PACTR201011000264179 |
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Study type:
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interventional |
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Study design:
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Parallel: different groups receive different interventions at same time during study, Randomised, Statistician will build a computer-generated random numbers table will be used to allocate subjects to groups. , Allocation will be concealed by placing group identification in sealed opaque envelopes,
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Countries of recruitment
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South Africa
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Contacts
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Name:
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Linzette
Morris |
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Address:
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140 Spencer Street
7460
Goodwood
South Africa |
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Telephone:
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+27 21 5925132 |
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Email:
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ldmorris@sun.ac.za |
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Affiliation:
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Researcher/Stellenbosch University |
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Name:
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Linzette
Morris |
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Address:
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140 Spencer Street
7460
Goodwood
South Africa |
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Telephone:
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+27 215925132 |
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Email:
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ldmorris@sun.ac.za |
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Affiliation:
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Researcher/Stellenbosch University |
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Key inclusion & exclusion criteria
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Inclusion criteria: Adult male and female subjects
Between ages of 18 and 65 years old
clinically diagnosed with FMS according to the American College Rheumatology (ACR) criteria [26] by a qualified rheumatologist subjectively report high PCS (more than 24 points) and TSK (more than 37 points) scores
able to speak, read English, Afrikaans and Xhosa
Exclusion criteria: diagnosed with other conditions not related to FMS i.e. cancer;
severe physical disabilities;
suffer from other chronic conditions i.e. systemic lupus erythmatosus, rheumatoid arthritis, etc;
previously been hospitalized for a major psychiatric disorder;
uncontrolled endocrine or allergic disorder; using medication other than the prescribed pharmacologic agents for FMS symptoms;
using any narcotics long-term;
currently or who have previously abused any illicit substances or alcohol;
diagnosed with epilepsy, or other conditions contraindicated in the use of visual exposures to stimuli;
contraindications which prohibit the use of fMRI, i.e. cardiac pacemakers, metal implants, claustrophobia, pregnancy and cochlear implants;
unable to discontinue intake of anti-depressants 4 weeks prior to commencement of study
Age minimum:
18 Year
Age maximum:
65 Year
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Fibromyalgia
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Primary Outcome(s)
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pain catastrophizing
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Secondary Outcome(s)
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Kinesiophobia
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Secondary ID(s)
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N10/05/184
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Source(s) of Monetary Support
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National Research Fund
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Harry Crossley Foundation
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Stellenbosch University Postgraduate merit award
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